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Completed

NCT Number: NCT04609371

PanDirect: Self-care Tools and Telephone Coaching for Depression and Anxiety During Pandemics

During pandemics older adults with chronic physical conditions are a particularly vulnerable population for unmet mental health needs. This is a consequence of a number of factors which include decreased access to their doctors because of restrictions in visits in order to decrease risk of disease transmission and because doctors are seconded to provide medical services in areas of high priority. Since Public Health authorities worry that pandemics may be a reality of the future, this study is being operationalized during the present COVID-19 pandemic in order to see what can be learned about different ways to provide mental health care under such constraints.

The study offers evidence-based approaches to managing feelings of anxiety or depression that may have existed prior to the onset of a pandemic, or that have arisen during a pandemic. It uses principles of cognitive behavioural therapy in which participants are offered self-care tools to help them develop strategies for dealing with their various symptoms. These tools have already been shown by the team to be effective in other contexts in studies DIRECT-sc (Effectiveness of a supported self-care intervention for depression compared to an unsupported intervention in older adults with chronic physical illnesses) and CanDIRECT (Effectiveness of a telephone-supported depression self-care intervention for cancer survivors).

The present study, PanDIRECT (Assisting Family Physicians with Gaps in Mental Health Care Generated by the COVID-19 Pandemic), aims to answer the following questions:

1. Can these tools be used in the community care of mental health problems during pandemics? 2. Are they acceptable to patients? 3. Using a randomized control trial, does lay-coaching of use of these tools improve their use and patient outcomes? 4. Do family practitioners value patient information sent to them at the end of the trial

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Key information

Conditions

Mental Health Wellness 1 Anxiety Disorders Behavior Behavioral Symptoms Coaching Depression Depression, Anxiety Mental Disorders Pandemic Self-care Tools

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Mary's Hospital Research Centre

Montreal, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 65+ years old
  • consented to be recontacted (participant in a previous study)

Exclusion criteria

  • moderate to severe cognitive impairment (using BOMC a brief cognitive screen) -unable to read in English or French (self-reported); hearing impairment (as judged by research staff);
  • currently receiving counseling or psychological therapy (as these treatments may conflict with the self-care interventions)
  • currently living in a long term care or other medicalized facility,
  • presenting suicidal intent (as identified through the final item of the PHQ-9 which will be asked at screening).

Treatment and study plan

Self-Care Tools

Behavioral

self-care tools only

Lay telephone coaching

Behavioral

coaching

Primary outcomes

  1. Consent rate

    Time frame: At recruitment

    Number of consenting participants out of total number contacted over the recruitment period

  2. Data completion rate

    Time frame: From recruitment launch to completion of follow-up (4 months)

    Investigators will report on rates of missing data from baseline and follow-up questionnaires

  3. Fidelity of intervention completion

    Time frame: A 8 week follow-up

    Logs and checklists will be used to evaluate completion of intervention, as per protocol

  4. Severity of depression symptoms

    Time frame: At baseline

    Using the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression

  5. Severity of depression symptoms

    Time frame: At 8 week follow-up

    Using the validated 9 item Patient Health Questionnaire (PHQ-9). Scores range from 0 to 27 - higher score indicates more severe depression

  6. Severity of anxiety symptoms

    Time frame: At baseline

    Using the validated 7 item General Anxiety Disorder (GAD-7) instrument. Scores range from 0 to 21 - higher score indicates more severe anxiety

  7. Severity of anxiety symptoms

    Time frame: At 8 week follow-up

    Using the validated 7 item General Anxiety Disorder (GAD-7) instrument. Scores range from 0 to 21 - higher score indicates more severe anxiety

  8. Use of health care services

    Time frame: At baseline

    Using questions developed by the team and administrative databases to assess use of hospital and mental health care services

  9. Use of health care services

    Time frame: At 8 week follow-up

    Using questions developed by the team and administrative databases to assess use of hospital and mental health care services

  10. Use of the self-care materials

    Time frame: At 8 week follow-up

    Using adherence questions developed by the team, not scored

Sponsors and collaborators

Lead sponsor

St. Mary's Research Center, Canada

Other

Registry information

Official study title

Assisting Family Physicians With Gaps in Mental Health Care Generated by the COVID-19 Pandemic: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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